Events

Notificaciones De Seguridad De Campo acerca de Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por N/A.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2005(02)
  • Fecha
    2005-03-14
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/durex-extra-safe-12-pack-condoms-and-durex-fetherlite-12-pack-condoms&id=639af825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The two above specified batches of condoms bearing the durex brand name are counterfeit products that do not meet the requirements of the european standard for condoms.
  • Acción
    The IMB advises that you: Check both the outer packet and the condom foil to see if the details given above are the  same as those outlined on the product in your possession. If you have identified that you have product with the details above return any such affected product in your possession to your local pharmacy. If you think you may have used the affected condoms and have any health concerns, please consult your General Practitioner for their advice. Please be advised that this notice only applies to the 12 pack size of condoms specified above and not to any other pack size.

Device

Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms
  • Modelo / Serial
    Product Name:        Durex Extra Safe 12 Pack Condoms Batch Number:        20602503 Expiry Date:            2007/11 Product Name:        Durex Fetherlite 12 Pack Condoms Batch Number:        VR3073 U / VR3073 C / VR3073 E / VR3073 € Expiry Date:            2008/02
  • Descripción del producto
    Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA